Regulatory Affairs for Phase I Clinical Trials

Understanding regulatory affairs strategies to expedite Phase I clinical trials compliance and licensing.

With the recent updates in the European Clinical Trials Directive there have been a number of changes to clinical trials regulations and guidelines. Regulatory adherence is imperative for obtaining and maintaining authorisation for a clinical trial.

This course will guide delegates through the steps required to obtain and maintain approval for Phase I clinical trials. This includes an interactive view of the documentation associated with regulatory approval. It will review case studies in order to help the delegates avoid the of Phase I regulatory submissions. Delegates
will leave with an understanding of the recent changes that have resulted from the mistakes of the past, as we move into the future.

■ Explore the latest guidelines and directives in regulatory affairs for Phase I clinical trials
■ Reduce the likelihood of your product being withdrawn after going to market
■ Understand the role of the regulatory bodies across different geographies
■ Ensure your service providers comply with Phase I regulatory requirements
■ Traverse the minefield of documentation necessary for approval of your Phase I clinical trial
■ Achieve winning Phase I submissions the first time – every time